Is the FDA’s Biosimilar Action Plan Adequate?

In July of this year, the US Food and Drug Administration (FDA) published a Biosimilar Action Plan (BAP). In light of a quickly evolving market for biosimilar and interchangeable products, the BAP sets foundational guidance to establish regulatory certainty with regard to approval. Some experts, however, argue that the plan does not sufficiently address several significant concerns.

In an exclusive interview with Cancer Network, Gary H. Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research and a professor of oncology and medicine at the University of Washington School of Medicine, does not think the BAP as it stands will prevent biosimilar companies from utilizing delay tactics, which limits prompt access to these agents.

“Despite the important elements of the plan and proposed actions to be taken, all of which I support, I do not see concrete steps indicated that would reign in the ‘gaming,’” said Lyman. “The FDA is somewhat limited in what it can do given US law and patent protections. However, I am somewhat concerned that they have not openly acknowledged such actions by originators to delay or stop biosimilar companies from competing on level playing fields.”

 “While we are seeing an increasing number of biosimilars being approved by the FDA, a number of these have not reached the market due to delaying tactics which are perhaps legal but are reducing or delaying access to these agents in the clinic. I don’t see that explicitly addressed in the action plan and there need to be steps taken to address this,” Lyman added.

The BAP also does not address the importance of public disclosure of the totality of evidence reviewed by the FDA at the top of approval, according to Lyman.

“It has become clear that FDA approval is necessary but not sufficient for integration of biosimilars into clinical guidelines and practice. Clinicians and professional organizations such as ASCO [the American Society of Clinical Oncology] and NCCN [the National Comprehensive Cancer Network] insist on seeing the available evidence either through peer-reviewed publications or at the time of public disclosure at an FDA advisory committee meeting. When the evidence is not available, this is likely to appropriately limit the utilization of a biosimilars in clinical practice. Again, this is not explicitly addressed in the action plan,” Lyman told Cancer Network.

Congress gave the FDA the power to apply laws that balance innovation in drug development and the facilitation of market competition. Some of the most notable advances in medicine have occurred in the realm of biological products. Following the expiration of patents and exclusivities on these biologics, prices can fall, thus proffering heightened access to patients and payers. 

According to the FDA, the BAP concentrates on the following four areas, taken verbatim from its publication.

1. Improving the efficiency of the biosimilar and interchangeable product development and approval process.

2. Maximizing scientific and regulatory clarity for the biosimilar product development community.

3. Developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors.

4.  Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.

The BAP is intended to be dynamic, and the FDA will continue to identify activities that can be incorporated into the program so as to better inform regulation. Furthermore, the FDA plans to consider  professional and patient feedback solicited at conferences and meetings.